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Letters, Testimony & Comments

BIO submits letters, testimony, and comments to government and regulatory bodies throughout the United States and around the world.

Featured Letters, Testimony, & Comments
ohn’s One-Year Anniversary Letter to BIO…
Dear Colleagues,This month marks my one-year anniversary as BIO’s CEO. Like most of us in biotech, this post has been a labor of love. At no time in my 25-year career in this industry have I ever witnessed such awe-inspiring science. Today, we…
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BIO Comments on Office of Management and Budget …
Re: BIO Comments on Office of Management and Budget (OMB) Statistical Policy Directive No. 8 North American Industry Classification System (NAICS)-Request forComments on Possible Revisions for 2027 (USBC–2024–0032)Dear Ms. Orvis,The Biotechnology…
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BIO Letter to HRSA on 340B Rebate Model
Under the 340B program, participating manufacturers must offer 340B pricing on their covered outpatient drugs by covered entities, as a condition of having those drugs federally payable under Medicare Part B and Medicaid. Critically, Congress…
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Agriculture and Weed Resistance
March 10, 2016
The environmental challenges of weed resistance are the same for biotech crops and conventional crops if farmers do not use herbicides as directed. Learn more about stewardship practices that help farmers better control weeds and how biotechnology…
Technological Innovation Program (TIP): NIST proposes new program support, promote, and accelerate innovation in the United States through high-risk, high-reward research in areas of critical national need.
March 10, 2016
BIO applauds NIST on implementation of TIP program and urges that personalized medicine be included as an area of "critical national need"
Cures Acceleration Network: BIO Strongly Supports the CAN Program
March 10, 2016
Implementation of CAN will help NIH-funded researchers bridge the precarious gap between basic research and the eventual development of new cures and treatments for many of the diseases we face today.
Cures Acceleration Network: Patient Group Letter
March 10, 2016
The letter, signed by approximately 85 patient groups, requests appropriation for CAN in FY2011
Sarbanes-Oxley in Financial Services Compromise: Sarbanes-Oxley 404(b) Legislative Text in the Wall Street Reform and Consumer Protection Act of 2009
March 10, 2016
BIO advocated for a provision in financial services reform that would ease regulatory burdens for small public biotechnology companies.
Sarbanes Oxley 404(b) recommendations made by the 2009 Government-Business Forum on Small Business Capital Formation
March 10, 2016
The 2009 Government-Business Forum on Small Business Capital Formation recommended a permanent exemption for small companies from Section 404(b) of Sarbanes-Oxley. Additionally, they recommended that the SEC increase the public float threshold for…
Pilot Circuit Breaker Proposal: SEC issues proposal on pilot circuit breaker program to combat abusive short selling
March 10, 2016
BIO commends the SEC on its pilot circuit breaker proposal and urges the use of biotech companies in such proposal
IFRS Roadmap: SEC requests comments on U.S. conversion to a set of global accounting standards
March 10, 2016
BIO provides comment letter to SEC generally supporting the IFRS roadmap while maintaining safeguards for emerging companies during transition.
Letter to the Honorable John Carey
March 10, 2016
Letter to the Honorable John Carey, Chairman of the Senate Committee on Finance and Financial Institutions in Ohio from BIO, regarding House Bill 66.
Questions for the District of Columbia Board of Pharmacy for the drafting of SafeRx
March 10, 2016
Frequently Asked Questions Document